# K062995: M2A-Magnum Tri-Spike Acetabular Component

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 31, 2006 after 29 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881288 (1988). 15 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.

## Most influential descendants
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K170359: Trinity™ Dual Mobility System (2017), 10 descendants of its own
- K161190: G7 Dual Mobility System, Active Articulation System (2016), 7 descendants of its own
- K191831: MobiliT Cup (2020), 3 descendants of its own

## Indications for use
The M2a-MagnumTM System is indicated for non-cemented use in patients requiring total hip replacement due to the following: Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis. Rheumatoid arthritis Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed total hip arthroplasty

Source page: https://510kreport.com/device/K062995
Methodology: https://510kreport.com/methodology